FDA 510(k) clearances — page 168
clearances on record, most recent first.
Clearances — page 168
16,701–16,800 of 176,479- K202952 — Amber Mill Q Series & Amber Mill Direct Series
- K210131 — ComfortGuard Surgical Isolation Gown
- K210288 — Disposable Manual Resuscitator
- K210745 — Heel Incision Safety Lancet
- K210898 — Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue)
- K210991 — Disposable Sterile Syringe, Disposable Sterile Syringe with Needle
- K211240 — ViperCross Support Catheters
- K211634 — Hypodermic Needle-Pro EDGE Safety Device
- K212048 — Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe)
- K212355 — Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large
- K202148 — E-Fit Infinity System (EF-2090 Controller and EF-100 Unit)
- K202916 — Balloon Guiding Catheter
- K203344 — Premilled Titanium Block System
- K203357 — HVT 2.0
- K210790 — Lateralized and Augmented Baseplates
- K210792 — Auxein Nailing System
- K210838 — PROWLER SELECT PLUS; PROWLER EX
- K210936 — Elvie Stride
- K211362 — SCAR 3
- K211444 — CellFX System
- K211451 — Disposable Surgical Mask (non sterile)
- K211500 — AMSCO 600 Medium Steam Sterilizer
- K211609 — ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert
- K211616 — ExcelsiusHub
- K212051 — RFA-1717DIG, RFA-1717DIC
- K212134 — Diagnostic X-ray System/PLX5200A
- K212323 — Instinct Plus Endoscopic Clipping Device
- K201157 — Prime BIOFOAM® Multi-Hole Shells
- K203739 — ELAN 4 Electro Motor System
- K210464 — Auto Disable Syringe
- K210619 — SKR 3000
- K210674 — Shoulder Pacemaker
- K210844 — DreamWear Silicone Pillows Mask
- K210897 — Disposable Nitrile Examination Gloves
- K211501 — Advantage-C PEEK Cervical lnterbody Fusion Device
- K211515 — Nitrile Examination Gloves
- K211516 — Disposable Vinyl Nitrile Synthetic Gloves Powder Free
- K212027 — TurboHawk Plus Directional Atherectomy System
- DEN210003 — SureTune4 Software
- K200657 — SmartGuard Anti-Snoring Device
- K201400 — npSIMS Negative Pressure Surgical Incision Management System (npSIMS)
- K202745 — Disposable medical face mask
- K203396 — DEKA SMARTPERIO
- K211793 — EzOrtho
- K212039 — CLAREON MONARCH IV IOL Delivery System
- K212105 — 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF
- K212324 — RenovoCath
- K212367 — IMRIS iMRI 3T V
- K202532 — Disposable Surgical Gowns
- DEN190056 — ADVIA Centaur Enhanced Liver Fibrosis (ELF)
- K201857 — Powder Free Nitrile Examination Glove Black and Dual Color White-Blue
- K202670 — Nam illumination probe with chopper
- K202705 — Prime and DYNASTY® Additive Manufacturing Shells
- K203029 — Auxilock Titanium Interference Screw
- K203486 — Otoplan
- K203607 — MOSS VRS Spinal System
- K203622 — Medical Gloves
- K203705 — Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)
- K203790 — GEM Premier 5000
- K210533 — Inset Reverse Total Shoulder System
- K210800 — IO Expandable Lumbar Interbody Fusion System
- K210887 — Altus Spine Sochi OCT Spinal System
- K211194 — Molekule Air Pro
- K211527 — Exo Iris
- K211551 — Wishbone HA
- K211699 — Nitrile Exam Gloves, Powder Free, Blue
- K211757 — Simplify Disc
- K211791 — Ez3D-i/E3
- K211846 — Discovery MI Gen2
- K211895 — BC Reflex Uni Knee System
- K211916 — IPS e.max One
- K212294 — Ethos Treatment Management, Ethos Treatment Planning
- K212297 — Omni Foot and Ankle Plating System
- DEN210013 — OsteoProbe
- K202425 — SurgiLattice scaffold
- K202652 — Servator P SALF Solution with THAM
- K202836 — GX Navigation Instrument System
- K203633 — Enteral Extension Sets
- K210203 — mmRNA appliance
- K210256 — CiRx (R) Surgical Mask
- K210317 — Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System
- K210362 — s-Clean Pre-Milled Abutment
- K210698 — ECOMA Level 2 Disposable Surgical Mask with Ear Loops
- K210749 — Empty EVA Bag
- K211066 — Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3
- K211104 — AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set
- K211319 — Purism Non-Sterile Powder Free Nitrile Examination Gloves
- K211328 — EIDON FA, EIDON, EIDON AF, EIDON UWFL
- K211462 — Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask
- K211576 — WYZ Surgical Mask
- K211584 — Oral Surgery Contra
- K211620 — Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less)
- K212185 — Golden Isles Pedicle Screw System
- K212296 — Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2
- K212304 — Callaly Tampliner (super plus absorbency)
- K203227 — Elecsys HCG STAT
- K210318 — Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System
- K210971 — EnteraLoc Flow
- K211233 — Hailie Sensor NF0109
- K211454 — Surgical mask
Data sourced from openFDA. This site is unofficial and independent of the FDA.